Systems and methods for using solid high-level disinfection chemistries to produce disinfectant solutions

ABSTRACT

Systems and methods for using solid high-level disinfection chemistries to producing disinfectant solutions. In an embodiment, an apparatus comprises: a first container and a second container. The first container is configured to receive water, sodium percarbonate and tetraacetylethylenediamine. The water, the sodium percarbonate, the tetraacetylethylenediamine react within the first container to produce a mixture comprising peroxyacetic acid. The second container is in fluid communication with the first container, wherein the second container is configured to receive an acid and the mixture. The mixture and the acid mix in the second container to produce a disinfectant solution having a pH between 5.0 and 7.0.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.16/337,009, filed on Mar. 27, 2019, which is a United States NationalFiling Under 35 U.S.C. § 371 from International Patent Application No.PCT/US17/53932, filed Sep. 28, 2017, which claims the benefit ofpriority to U.S. Provisional Patent Application Ser. No. 62/400,774filed Sep. 28, 2016 and also claims priority to U.S. Provisional PatentApplication Ser. No. 62/452,666 filed Jan. 31, 2017. These applicationsare incorporated herein by reference, in their entireties.

TECHNICAL FIELD

Embodiments of the present disclosure relate to disinfectant solutions.More specifically, embodiments of the present disclosure relate toproducing disinfectant solutions from solid chemistries, which are usedfor disinfecting a medical device.

BACKGROUND

Many medical devices may be reused on different patients. Before amedical device is used on a subsequent patient, however, the medicaldevice may need to be reprocessed. For example, after an endoscope isused on a patient, a number of steps are required to reprocess theendoscope, so that the endoscope can be used on another patient.Included in the steps of reprocessing an endoscope is disinfecting anendoscope, using a disinfectant solution. Conventionally, liquiddisinfectants are shipped by a manufacturer to a hospital or otherfacility. The hospital or other facility then uses the liquiddisinfectant chemistries to disinfect an endoscope.

SUMMARY

Embodiments of the present disclosure relate to apparatus and methodsfor producing disinfectant solutions from solid chemistries, for usewith disinfecting a medical device. Example embodiments include, but arenot limited to, the following.

In one aspect, the invention is directed to an apparatus configured toproduce a disinfectant solution for use with disinfecting a medicaldevice. The apparatus includes a first container configured to receivewater, sodium percarbonate and tetraacetylethylenediamine, wherein thewater, the sodium percarbonate and the tetraacetylethylenediamine reactwithin the first container to produce a mixture comprising peroxyaceticacid and having a pH between 9.0 and 14.0; and a second container influid communication with the first container, the second containerconfigured to receive an acid and the mixture from the first container,wherein the mixture and the acid mix in the second container to producea disinfectant solution having a pH between 5.0 and 7.0.

In another aspect, the invention is directed to a method for producing adisinfectant solution for disinfecting a medical device. The methodincludes combining water, sodium percarbonate andtetraacetylethylenediamine to produce a mixture comprising peroxyaceticacid, wherein the peroxyacetic acid has a concentration of at least 500parts per million; combining an acid with the mixture to form thedisinfectant solution having a pH between 5.0 and 7.0; and contacting amedical device with the disinfectant solution within 24 hours of formingthe disinfectant solution. In one embodiment, the disinfectant solutionmay contact a medical device between 5 minutes to 10 minutes.Alternatively, the disinfectant solution may contact the medical devicefor a shorter period of time or a longer period of time.

In another aspect, the invention is directed to an apparatus configuredto produce a disinfectant solution for use with disinfecting a medicaldevice. The apparatus includes a first container including sodiumpercarbonate and tetraacetylethylenediamine. The first containerincludes a first aperture configured to receive water, wherein thewater, the sodium percarbonate and the tetraacetylethylenediamine reactwithin the first container to produce a mixture comprising peroxyaceticacid. In one embodiment, the first container is configured to filterundissolved portions of the sodium percarbonate and thetetraacetylethylenediamine. The first container includes a secondaperture that the mixture exits through. A second container isconfigured to receive the mixture from the first container via thesecond aperture, the second container comprising an acid, wherein themixture and the acid mix in the second container to produce adisinfectant solution having a pH between 5.0 and 7.0.

In another aspect, the invention is directed to a method includingproviding, to a user, sodium percarbonate and tetraacetylethylenediaminein a first compartment of a package and an acid in a second compartmentof the package; providing instructions to the user to combine the sodiumpercarbonate and the tetraacetylethylenediamine with water, wherein thewater, sodium percarbonate, tetraacetylethylenediamine react within thefirst container to produce a mixture comprising peroxyacetic acid; andproviding instructions to the user to combine the mixture with the acid,wherein the mixture and the acid produce a disinfectant solution for usewith disinfecting a medical device, wherein the disinfectant solutionhas a pH between 5.0 and 7.0.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. Accordingly, the drawingsand detailed description are to be regarded as illustrative in natureand not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram of an illustrative disinfectantsystem for use with disinfecting a medical device, in accordance withsome embodiments of the present disclosure.

FIG. 2 is another schematic illustration of a disinfectant system, inaccordance with some embodiments of the present disclosure.

FIG. 3 is a schematic illustration of an expanded view of the firstcontainer depicted in FIG. 2 , in accordance with embodiments of thepresent disclosure.

FIG. 4 is a flow diagram depicting one or more methods, in accordancewith the embodiments of the disclosure.

DETAILED DESCRIPTION

While the disclosed subject matter is amenable to various modificationsand alternative forms, specific embodiments have been shown by way ofexample in the drawings and are described in detail below. Theintention, however, is not to limit the disclosure to the particularembodiments described. On the contrary, the disclosure is intended tocover all modifications, equivalents, and alternatives falling withinthe scope of the disclosure as defined by the appended claims.

As the terms are used herein with respect to ranges of measurements(such as those disclosed immediately above), “about” and “approximately”may be used, interchangeably, to refer to a measurement that includesthe stated measurement and that also includes any measurements that arereasonably close to the stated measurement, but that may differ by areasonably small amount such as will be understood, and readilyascertained, by individuals having ordinary skill in the relevant artsto be attributable to measurement error, differences in measurementand/or manufacturing equipment calibration, human error in readingand/or setting measurements, adjustments made to optimize performanceand/or structural parameters in view of differences in measurementsassociated with other components, particular implementation scenarios,imprecise adjustment and/or manipulation of objects by a person ormachine, and/or the like.

As stated above, conventionally, liquid disinfectant chemistries areshipped by a manufacturer to a hospital or other facility that uses theliquid disinfectant chemistries to disinfect medical devices. Shippingliquid disinfectant chemistries, however, may have a number of drawbacksincluding, but not limited to, higher shipping costs than solidchemistries, limited shelf life, restricted method of shipment (e.g.,only ground shipments) and/or the like. Accordingly, there is a need inthe art for improved disinfectant chemistries used to disinfect medicaldevices.

While the present disclosure discusses using a solid high-leveldisinfectant for disinfecting an endoscope, in some embodiments, thesolid high-level disinfectant may be used on other medical devices, aswell. As such, the present disclosure is not limited to using the solidhigh-level disinfectant, as disclosed herein, when disinfecting anendoscope.

FIG. 1 is a schematic block diagram of an illustrative system 100 forproducing a disinfectant for disinfecting a medical device, inaccordance with some embodiments of the present disclosure. Due to theillustrative system 100, solid chemistries 102, 104 may be shipped to ahospital or other facility, instead of liquid disinfectant chemistries.As such, shipping costs may be reduced. Additionally or alternatively,in some embodiments, the solid chemistries 102, 104 may be shipped byair instead of ground and/or the solid chemistries 102, 104 may be morestable than liquid disinfectant chemistries. Additionally oralternatively, in some embodiments, the solid chemistries 102, 104 maybe non-hazardous and the byproducts produced by the system 100, usingthe solid chemistries 102, 104, may be biodegradable, non-toxic andnon-sensitizing. Additionally or alternatively, in some embodiments, thepH of a disinfectant produced by the system 100 may be approximatelyneutral, so that neutralization may not be required before disposal ofthe disinfectant. Additionally or alternatively, a disinfectant solutionproduced by the system 100 may be produced on site by the facility thatuses the disinfectant solution to disinfect a medical device, so thatthe stability of the disinfectant solution may not be as imperative asother disinfectant solutions that are not produced on site.

As stated above, the system 100 includes solid chemistries 102, 104.Additionally, in some embodiments, the system 100 may include a liquid106, a pump 108 and a first container 110. In embodiments, the solidchemistries 102, 104 and the liquid 106 may be coupled to the firstcontainer via one or more conduits (not shown). In some embodiments, thesolid chemistries 102, 104 may be combined with the liquid 106 in thefirst container 110 to produce a fluid mixture 112. In some embodiments,the first container 110 may be made of any material capable of retainingthe solid chemistries 102, 104 before and/or after the solid chemistriesare combined with the liquid 106. For example, the first container 110may be glass, plastic, metal, and/or the like.

In some embodiments, to facilitate the combination of the solidchemistries 102, 104 and the liquid 106, the pump 108 may pump theliquid 106 into the first container 110 at a first flow rate. The firstflow rate may be a turbulent flow, which may facilitate the combinationof the solid chemistries 102, 104 and the liquid 106 in the firstcontainer 110. Examples of first flow rates that may be produced by thepump 108 pumping the liquid 106 into the first container 110 includegreater than about 0.5 gallons/minute (gal/min), greater than about 0.75gal/min, greater than about 1.0 gal/min, greater than about 1.25gal/min, greater than about 1.5 gal/min, greater than about 1.75gal/min, greater than about 2.0 gal/min and/or the like. However, theseare only examples and not meant to be limiting.

Additionally or alternatively, to facilitate the combination of thesolid chemistries 102, 104 and the liquid 106, a mixer 114 may beincorporated into, included in, and/or coupled to the first container110. Before, during or after the liquid 106 is disposed in the firstcontainer 110, the mixer 114 may be started, so that when the liquid 106is in the first container, the mixer 114 can facilitate combining thesolid chemistries 102, 104 and the liquid 106. The mixer may be any kindof mixing device that is capable of mixing liquids.

The solid chemistries 102, 104 and the liquid 106 are selected to form adisinfectant mixture. In some embodiments, the solid chemistries 102,104 may be sodium percarbonate and tetraacetylethylenediamine (TAED),respectively, and the liquid 106 may be water. Additionally oralternatively, one of the solid chemistries may be sodium perborate. Insome embodiments where the solid chemistry 102 is sodium percarbonateand the liquid 106 is water, the sodium percarbonate may dissolve inwater 106 to produce sodium carbonate and hydrogen peroxide, accordingto equation (1):

In some embodiments, the hydrogen peroxide resulting from the reactionof water and sodium percarbonate may have concentrations betweenapproximately 3000 ppm and 6000 ppm, specifically between 4000 ppm and5000 ppm. In some embodiments, the hydrogen peroxide produced bydissolving the sodium percarbonate in water reacts with the TAED toproduce peroxyacetic acid (also known as peracetic acid), a mainingredient used to disinfect an endoscope, and diacetylethylenediamine(DAED), according to equation (2):

In some embodiments, the fluid mixture 112 that is produced by thecombination of the solid chemistries 102, 104 and the liquid 106 mayinclude peroxyacetic acid produced according equation (2). In someembodiments, the fluid mixture 112 may also include the DAED that isproduced according equation (2).

In some embodiments, to facilitate the reaction of the hydrogen peroxideand TAED, the water in which the sodium percarbonate dissolves may be ata desired temperature. In some embodiments, the water may be greaterthan or equal to about 30° C., 35° C., 40° C., 50° C., 60° C., 70° C.,80° C., 90° C., 100° C. and/or the like since a temperature of 30° C.may facilitate the reaction of the hydrogen peroxide, produced from thesodium percarbonate in water, and the TAED.

In some embodiments, sodium percarbonate, TAED and water may be providedin amounts to create a desired amount of peroxyacetic acid. For example,sodium percarbonate, TAED and water may be provided in sufficientamounts to produce peroxyacetic acid in concentrations between: about500 parts per million (ppm) and about 2200 ppm, between about 800 partsper million (ppm) and about 1600 ppm, between about 1000 ppm and about1400 ppm, approximately 1200 ppm, and/or the like. As another example,the amount of desired peroxyacetic acid produced may be greater than:about 500 ppm, about 800 ppm, about 1000 ppm, about 1200 ppm, about 1400ppm, about 1600 ppm and/or the like. As even another example, the amountof desired peroxyacetic acid produced may be between less than: about1600 ppm, about 1400 ppm, about 1200 ppm, about 1000 ppm, about 800 ppm,about 500 ppm, and/or the like. However, these are only examples and notmeant to be limiting. In one example, to produce peroxyacetic acid inquantities between about 1200 ppm and about 1500 ppm, about 4 liters ofwater may be combined with about 23.3 grams (g) of TAED and about 16.6 gof sodium percarbonate. This example is given for illustration purposesonly and not meant to be limiting.

The fluid mixture 112 produced from the combination of the solidchemistries 102, 104 and the liquid 106 may have a pH of approximatelybetween 9 and 14. A fluid mixture 112 with a high pH (i.e., above a pHof about 9) may corrode materials more quickly than a mixture with alower pH (i.e., a pH of about 7 or lower). A fluid mixture 112 with ahigh pH may also have a strong odor. As such, if the fluid mixture 112,which has a high pH, were used to disinfect a medical device, the fluidmixture 112 may have to be neutralized after the fluid mixture 112 isused to disinfect a medical device, but before disposing of the fluidmixture 112. Accordingly, in embodiments, the pH of the fluid mixture112 may be lowered.

To lower the pH of the fluid mixture 112, the fluid mixture 112 may becombined with an acid 116, wherein the acid 116 is originally in powderform. As illustrated in FIG. 1 , the fluid mixture 112 may betransferred to a second container 118 and combined with the acid 116.Alternatively, the acid 116 may be added to the fluid mixture 112 in thefirst container 110. In some embodiments, the first container 110 andthe second container 118 may be coupled to each other via one or moreconduits (not shown). In some embodiments, the second container 118 maybe any container capable of retaining the fluid mixture 112 and the acid116. For example, the second container 118 may be made of glass,plastic, metal and/or the like.

In some embodiments, the solid chemistries 102, 104 and the acid 116 maybe included in a single package and shipped to a facility that combinesthe solid chemistries 102, 104 with a liquid, as described above, andthen combines the acid 116 with the mixture resulting from the mixtureof the solid chemistries 102, 104 and the liquid. In some embodiments,the solid chemistries 102, 104 and the acid 116 are included indifferent compartments of the single package. As described above, thismay eliminate the drawbacks of shipping a liquid disinfectant. Forexample, by shipping solid chemistries 102, 104 and an acid 116,shipping costs may be less than when shipping liquid disinfectants, theshelf life of the solid chemistries 102, 104 and the acid 116 may belonger than liquid disinfectants, and the solid chemistries 102, 104 andthe acid 116 may be shipped via more methods than shipping liquiddisinfectants (e.g., via air).

In some embodiments, before the fluid mixture 112 is neutralized withthe acid 116, the fluid mixture 112 may be filtered using a filter 120.While the filter 120 is illustrated as being disposed in the firstcontainer 110, in some embodiments, the filter 120 may be coupled to anoutlet of the first container 110, coupled to an inlet of the secondcontainer 110, coupled to and/or incorporated into a conduit thatconnects the first container 110 to the second container 118,incorporated into the first container 110, disposed between the firstand second containers 110, 118 and/or the like. Additionally oralternatively, the first container 110 may be made of such a materialthat the first container 110 acts as the filter 120, as described belowin relation to FIG. 2 .

In some embodiments, the filter 120 may be a filter capable of filteringundissolved portions of the solid chemistries 102, 104. For example, inone embodiment, the fluid mixture 112 is directed through filter 120,and filter 120 prevents large particles or items from passing throughthe filter (i.e., undissolved portions of the solid chemistries 102and/or 104), while allowing the fluid mixture 112 to pass through thefilter 120. For example, the filter 120 may be a 100 micron filter(i.e., the average pore size is 100 microns), a 20 micron filter (i.e.,the average pore size is 20 microns), a 10 micron filter (i.e., theaverage pore size is 10 microns), a 5 micron filter (i.e., the averagepore size is 5 microns), a 1 micron filter (i.e., the average pore sizeis 1 micron), a 0.5 micron filter (i.e., the average pore size is 0.5microns), a 0.1 micron filter (i.e., the average pore size is 0.1microns) and/or the like.

In embodiments where the fluid mixture 112 is combined with the acid 116in a second container 118, the fluid mixture 112 may be transferred tothe second container 118 by the pump 108. Additionally or alternatively,a second pump 122 may be configured to pump the fluid mixture 112 fromthe first container 110 to the second container 118. Additionally oralternatively to pumping the fluid mixture 112 from the first container110 to the second container 118, the second pump 122 may be used to pumpthe acid 116 into the second container 118. In some embodiments, thepump 108 and/or the pump 122 may facilitate the mixing of the fluidmixture 112 and the acid 116 by pumping the fluid mixture 112 into thesecond container 118 at a second flow rate. That is, for example, thesecond flow rate may cause a turbulence of the fluid mixture 112 and/orthe acid 116 in the second container 118, which facilitates the mixingof the fluid mixture 112 and the acid 116. Examples of second flow ratesthat may be produced by the pump 108 pumping the fluid mixture 112 intothe second container 118 include greater than about 0.5 gal/min, greaterthan about 0.75 gal/min, greater than about 1.0 gal/min, greater thanabout 1.25 gal/min, greater than about 1.5 gal/min, greater than about1.75 gal/min, greater than about 2.0 gal/min and/or the like. However,these are only examples and not meant to be limiting.

Additionally or alternatively, to facilitate the combination of thefluid mixture 112 and the acid 116, a mixer 124 may be incorporatedinto, included in, and/or coupled to the second container 124. Before,during or after the fluid mixture 112 and the acid 116 are disposed inthe second container 118, the mixer 124 may be started to facilitate thecombination of the fluid mixture 112 and the acid 116 after the fluidmixture 112 and the acid 116 are combined in the second container 118.The mixer 124 may be any kind of mixing device that is capable of mixingliquids.

As stated above, the acid 116 may be used to lower the pH of the fluidmixture 112. In some embodiments, the acid 116 may be mixed with thefluid mixture 112 so that the combined solution, also referred to hereinas the disinfectant solution 126, has a desired, neutral or relativelyneutral pH. For example, the acid 116 may have a lower pKa than thefluid mixture 112 in order to lower the pH of the fluid mixture 112, sothat the combined solution 126 has a pH of one or more of the following:a pH between about 5.0 and 7.0, a pH between about 6.0 and 7.0, and/or apH of approximately 6.5 and/or the like. Examples of acids may be, butare not limited to, solid organic acids, such as glutaric acid, oxalicacid, malic, acid, citric acid, salicylic acid and/or the like andorganic weak acids, such as citric acid monohydrate.

In some embodiments, to lower the pH of the fluid mixture 112, aspecific quantity of acid 116 may be used. In one example, if citricacid is used as the solution to lower the pH of the fluid mixture 112and if quantities of about 4 liters of water, about 23.3 grams (g) ofTAED and about 16.6 g of sodium percarbonate were used to produce thefluid mixture 112, then about 16.6 g of citric acid may be added to thefluid mixture 112 to produce a combined solution 126 that has a pHbetween about 5.0 and 7.0. However, this example is only forillustrative purposes and is not meant to be limiting.

In some embodiments, the acid 116 may be included in a surfactant (e.g.,Pluronic F68™ or Pluronic F68 LF, available from ThermoFisherScientific) and combined with the fluid mixture 112, to facilitate thecombination of the acid 116 and the fluid mixture 112. In one example,assuming quantities of about 4 liters of water, about 23.3 grams (g) ofTAED and about 16.6 g of sodium percarbonate were used to produce thefluid mixture 112, then about 0.08 g of Pluronic F68 LF may be added toproduce a combined solution 126, also referred to herein as adisinfectant solution 126.

In some embodiments, the acid 116 may be combined with the surfactant orother liquid that is at a lower temperature than the fluid mixture 112so that the disinfectant solution 126 will have a lower temperature thanthe mixture 112. For example, the acid 116 may be combined with asurfactant or other liquid that is at a temperature so that thedisinfectant solution 126 will have a temperature of approximately 20°C., 25° C., 30° C., 35° C., 40° C. and/or the like.

After the fluid mixture 112 and the acid 116 are combined to produce adisinfectant solution 126 with a desired pH, the disinfectant solution126 may be used to disinfect a medical device 128. In embodiments, thesecond container 118 and the medical device 128 may be coupled to eachother via one or more conduits (not shown). In embodiments, thedisinfectant solution 126 may be transferred from the second container118 to the medical device via the pump 108, the pump 122 and/or the pump130. Examples of medical devices 128 include, but are not limited to:endoscopes and dental equipment.

In some embodiments, before the disinfectant solution 126 is used todisinfect a medical device 128, the disinfectant solution 126 may befiltered by a filter 132. In some embodiments, the filter 132 may be afilter capable of filtering out undissolved portions of the solidchemistries 102, 104 and/or other particulate matter in the disinfectantsolution 126. In some embodiments, the disinfectant solution 126 mayinclude portions of the solid chemistries 102, 104 because the filter120 may not be included in the system 100 and/or the solid chemistries102, 104 were not completely filtered by the filter 120. The filter 132may be, for example, a 100 micron filter (i.e., the average pore size is100 microns), a 20 micron filter (i.e., the average pore size is 20microns), a 10 micron filter (i.e., the average pore size is 10microns), a 5 micron filter (i.e., the average pore size is 5 microns),a 1 micron filter (i.e., the average pore size is 1 micron), a 0.5micron filter (i.e., the average pore size is 0.5 microns), a 0.1 micronfilter (i.e., the average pore size is 0.1 microns) and/or the like.While the filter 132 is illustrated as being disposed external to thesecond container 118, in some embodiments, the filter 132 may be coupledto an outlet of the second container 132, coupled to an inlet of themedical device 128, coupled to and/or incorporated into a conduit thatconnects the second container 118 to the medical device, incorporatedinto the second container 118, disposed between the second container 118and the medical device 128 and/or the like.

As described above, due to the embodiments of FIG. 1 , solid chemistries102, 104 may be shipped to the facility that is disinfecting the medicaldevice 128, so that the disinfectant solution 126 can be produced by thefacility, instead of shipping liquid disinfectants to the facility thatis disinfecting the medical device 128. As such, the disinfectantsolution 126 may be used by the facility soon after the disinfectantsolution 126 is produced (e.g., 5 minutes, 10 minutes, 30 minutes, 1hour, 2 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 daysand/or the like). Accordingly, the stability of the disinfectantsolution 128 may not be a concern, compared to a disinfectant solutionthat is produced off site and shipped to the facility. Additionally oralternatively, another benefit compared to conventional disinfectantsolutions that are produced off site may be that little or no aceticacid may be used in producing the disinfectant solution 128.

FIG. 2 is another schematic illustration of a disinfectant system 200,in accordance with some embodiments of the present disclosure. Thedisinfectant system 200 includes a liquid source 202. In someembodiments, the liquid 204 may have some or all of the samecharacteristics of the liquid 106 discussed above in FIG. 1 . Forexample, the liquid 204 may be water. In the illustrated embodiments,liquid 204 is released by the liquid source 202. After being released bythe liquid source 202, the liquid 204 may fall, e.g., due to gravity,and/or may be forced or injected into an orifice 206 located on the topportion 208 of a first container 210. In some embodiments, the liquidsource 202 may be disposed on top of the first container 210 and/or aconduit (not shown) may couple the liquid source 202 to the orifice 206.

An illustrative exploded view of the first container 210 is depicted inFIG. 3 . In some embodiments, the first container 210 includes one ormore solid chemistries 308 (depicted in FIG. 3 ) and a filter 310(depicted in FIG. 3 ). The solid chemistry 308 of the first container210 may be disposed in the filter 310 of the first container 210. Insome embodiments, the solid chemistry 308 and the liquid 204 may combineto produce a fluid mixture 212. In some embodiments, the solid chemistry308 may have some or all of the same characteristics as the solidchemistries 102, 104 described above in relation to FIG. 1 . Forexample, the solid chemistry 308 of the first container 210 may includesodium percarbonate and TAED. Additionally or alternatively to sodiumpercarbonate, the solid chemistry 308 may include sodium perborate.Additionally or alternatively, the filter 310 may have some or all ofthe same characteristics as the filter 120 depicted in FIG. 1 . Forexample, the filter 310 may be a 100 micron filter, a 20 micron filter,a 10 micron filter, a 5 micron filter, a 1 micron filter, a 0.5 micronfilter, a 0.1 micron filter and/or the like. Additionally oralternatively, the fluid mixture 212 may have some or all of the samecharacteristics as the fluid mixture 112 depicted in FIG. 1 . Forexample, the fluid mixture 212 may include peroxyacetic acid, asdescribed below.

In an example where the liquid 204 is water and the solid chemistry 308is sodium percarbonate and TAED, once the water 204 is deposited intothe first container 210, the sodium percarbonate dissolves in the waterto produce hydrogen peroxide, as described above in relation to FIG. 1 .In some embodiments, the hydrogen peroxide may have concentrationsbetween approximately 3000 ppm and 6000 ppm, specifically between 4000ppm and 5000 ppm. After which, the hydrogen peroxide reacts with theTAED to produce peroxyacetic acid and DAED, as described above inrelation to FIG. 1 . In some embodiments, the force on the liquid 204due to gravity and/or an external force applied to the liquid 204 (e.g.,by a pump) may facilitate combining the liquid 204 and the solidchemistry 308.

In some embodiments, an amount of sodium percarbonate, TAED and watermay be used to create a desired amount of peroxyacetic acid. Forexample, the amount of desired peroxyacetic acid produced by thedisinfectant system 200 may be one or more of the followingconcentrations: between 500 parts per million (ppm) and about 22002200ppm, between about 800 parts per million (ppm) and about 1600 ppm,between about 1000 ppm and about 1400 ppm, approximately 1200 ppm and/orthe like. As another example, the amount of desired peroxyacetic acidproduced may be greater than: about 500 ppm, about 800 ppm, about 1000ppm, about 1200 ppm, about 1400 ppm, about 1600 ppm, and/or the like. Aseven another example, the amount of desired peroxyacetic acid producedmay be between less than: about 1600 ppm, about 1400 ppm, about 1200ppm, about 1000 ppm, 800 ppm, 500 ppm, and/or the like. However, theseare only examples and not meant to be limiting. To produce peroxyaceticacid in quantities between 1200 ppm and 1500 ppm, about 0.5 liters ofwater may be used, about 2.91 grams (g) of TAED may be used and about2.08 g of sodium percarbonate may be used. This example is given forillustration purposes only and is not meant to be limiting.

As stated above, the solid chemistry 308 may be disposed in a filter310. In some embodiments, the filter 310 may allow the fluid mixture212, (e.g., peroxyacetic acid) to pass through the filter 310, butretain the solid chemistry 308 before the liquid 204 is added to thesolid chemistry 308. In some embodiments, the size of the filter 310(e.g., a 100 micron filter, a 20 micron filter, a 10 micron filter, a 5micron filter, a 1 micron filter, a 0.5 micron filter, a 0.1 micronfilter and/or the like) may be selected so that the liquid 204 and/orthe hydrogen peroxide is slowly transmitted through the filter 310. Theslow transmission of the liquid 204 and/or the hydrogen peroxide mayfacilitate the combining of the liquid 204 and the solid chemistry 308to produce the fluid mixture 212.

Once the solid chemistry 308 and the liquid 204 combine to produce thefluid mixture 212, the fluid mixture 212 is transmitted through a secondorifice 214, on the bottom portion 216 of the first container 210, to asecond container 218. In embodiments, the second orifice 214 may besized to facilitate a slow exit of the fluid mixture 212 from the firstcontainer 210. The slow exit of the fluid mixture 212 from the firstcontainer 210 may facilitate the combining of the liquid 204 and thesolid chemistry 308 to produce the fluid mixture 212, similar toselecting a filter 310 that facilitates a slow transmission of the fluidmixture 212 through the filter 310.

The second container 218 may include an acid 220 to facilitate loweringthe pH of the fluid mixture 212, as described above in relation to FIG.1 , wherein the acid 220 is originally in powder form. That is, forexample, the fluid mixture 212 and the acid 220 may combine to produce acombined solution 222, also referred to herein as a disinfectantsolution 222. The acid 220 may have some or all of the samecharacteristics as the acid 116 depicted in FIG. 1 . Examples of acids220 may be, but are not limited to, solid organic acids, such asglutaric acid, oxalic acid, malic, acid, citric acid, salicylic acidand/or the like. In one example, assuming citric acid or citric acidmonohydrate is used as the solution to lower the pH of the fluid mixture212 and assuming quantities of about 0.5 liters of water, about 2.91grams (g) of TAED and about 2.08 g of sodium percarbonate were used toproduce the fluid mixture 212, then about 2.075 g of citric acid may beadded to the fluid mixture 212 to produce a combined solution that has apH between about 5.0 and 7.0. However, this example is only forillustrative purposes and is not meant to be limiting.

In some embodiments, the fluid mixture 212 may fall, due, e.g., togravity, and/or may be forced out of the orifice 214. In someembodiments, the force on the fluid mixture 212 due to gravity and/or anexternal force applied to the fluid mixture 212 (e.g., by a pump) mayfacilitate combining the fluid mixture 212 and the acid 220.Additionally or alternatively, in some embodiments, a mixer (not shown)may be incorporated into, included in, and/or coupled to the secondcontainer 218. Before, during or after the fluid mixture 212 and theacid 220 are in the second container 220, the mixer may be started sothat when the fluid mixture 212 and the acid 220 are in the secondcontainer, the combination of the fluid mixture 212 and the acid 220 maybe facilitated by the mixer. The mixer may be any kind of mixing devicethat is capable of mixing liquids. Additionally or alternatively, insome embodiments, the acid 220 may be included in a surfactant (e.g.,Pluronic F68™ or Pluronic F68 LF) to facilitate the combination of thefluid mixture 212 and the acid 220. Additionally or alternatively, theacid 220 may be combined with the surfactant or other liquid that is ata lower temperature than the fluid mixture 212 so that the disinfectantsolution 222 will have a lower temperature than the fluid mixture 212.For example, the acid 220 may be combined with a surfactant or otherliquid that is at a temperature so that the disinfectant solution 222will have a temperature of approximately 20° C., 25° C., 30° C., 35° C.,40° C. and/or the like.

Additionally or alternatively, the combined solution 222 of the fluidmixture 212 and the acid 220 may have some or all of the samecharacteristics of the combined solution 126 depicted in FIG. 1 . Forexample, after the fluid mixture 212 and the acid 220 are combined toproduce the disinfectant solution 222 with a desired pH, thedisinfectant solution 222 may be used to disinfect a medical device 224(e.g., an endoscope and/or dental equipment).

As stated above, FIG. 3 is a schematic illustration of an expanded viewof the first container 210 depicted in FIG. 2 , in accordance with someembodiments of the present disclosure. The first container 210 includesatop portion 208 that includes the orifice 206. In some embodiments, thetop portion 208 may be coupled to a bottom portion 216 of the firstcontainer 210 via a threading.

In the illustrated embodiment, a filter 310 is disposed in the bottomportion 216 of the first container 210. The filter 310 may have some orall of the same characteristics as the filter 120 depicted in FIG. 1 .For example, the filter 310 may be a 100 micron filter, a 20 micronfilter, a 10 micron filter, a 5 micron filter, a 1 micron filter, a 0.5micron filter, a 0.1 micron filter and/or the like. In some embodiments,a stabilizing structure (not shown), for example, a wire structure, maybe used to maintain the shape of the filter 310. The stabilizingstructure may be used in addition to or in alternative to the bottomportion 216.

The first container 210 also includes a solid chemistry 308 disposed inthe filter 310. Additionally or alternatively, the solid chemistry 308may have some or all of the same characteristics as the solidchemistries 102, 104 depicted in FIG. 1 . For example, the solidchemistry 308 may be and/or include sodium percarbonate and/or TAED andbe of amounts to produce peroxyacetic acid in concentrations of one ormore of the following: between 500 parts per million (ppm) and about2200 ppm, between about 800 parts per million (ppm) and about 1600 ppm,between about 1000 ppm and about 1400 ppm, approximately 1200 ppm and/orthe like.

As described above in relation to FIG. 2 , a liquid (e.g., the liquid106 depicted in FIG. 1 , the liquid 204 depicted in FIG. 2 ) may betransmitted through the orifice 206 and combined with the solidchemistry 308 in the filter 310 of the first container 210. In someembodiments, sodium percarbonate (i.e., a component of the solidchemistry 310) may dissolve in water to produce hydrogen peroxide. Thehydrogen peroxide may react with TAED (i.e., a component of the solidchemistry 308) to produce peroxyacetic acid and DAED. In someembodiments, the force on the liquid 204 due to gravity and/or anexternal force applied to the liquid may facilitate combining the liquidand the solid chemistry 308 to produce a mixture (e.g., the mixture 112depicted in FIG. 1 and/or the fluid mixture 212 depicted in FIG. 2 ),which is then transmitted through the second orifice 214.

FIG. 4 is a flow diagram depicting at least one method 400, inaccordance with the some embodiments of the disclosure. The method 400includes providing at least one solid chemistry (block 402). In someembodiments, the solid chemistry may have one or more of the samecharacteristics as the solid chemistries 102, 104 depicted in FIG. 1 ,and/or the solid chemistry 308 depicted in FIG. 3 . For example, thesolid chemistry may include sodium percarbonate and TAED. Additionallyor alternatively to including sodium percarbonate, the solid chemistrymay include sodium perborate. As another example, the solid chemistrymay include amounts to produce peroxyacetic acid in concentrations ofone or more of the following: between 500 parts per million (ppm) andabout 2200 ppm, between about 800 parts per million (ppm) and about 1600ppm, between about 1000 ppm and about 1400 ppm, approximately 1200 ppmand/or the like.

In some embodiments, the method 400 may include providing instructionsto a user on how to use the solid chemistry to make a disinfectantsolution (block 404). In some embodiments, the instructions may includeone or more of the following steps of method 400. For example, by way ofillustration and not of limitation, the instructions may include one ormore of the following steps: 408, 410, 412, 414, 416, 418 and/or 420,each of which is discussed in more detail below.

In some embodiments, the method 400 may include receiving a liquid(block 406). In some embodiments, the liquid may be received by a firstcontainer (e.g., the first container 110 depicted in FIG. 1 and/or thefirst container 210 depicted in FIGS. 2 and 3 ) from a liquid source(e.g., the liquid source 202 depicted in FIG. 2 ) via a conduit and/orvia an orifice (e.g., the orifice 206 depicted in FIGS. 2 and 3 ). Insome embodiments a pump (e.g., the pump 108 depicted in FIG. 1 ) maypump the liquid from the liquid source to the first container. In someembodiments, the pump may pump the liquid from the liquid source to thefirst container at a flow rate of, for example, greater than about 0.5gallons (gal)/minute (min), greater than about 0.75 gal/min, greaterthan about 1.0 gal/min, greater than about 1.25 gal/min, greater thanabout 1.5 gal/min, greater than about 1.75 gal/min, greater than about2.0 gal/min and/or the like. Additionally or alternatively, gravity mayfacilitate the liquid being received by the first container, forexample, as explained above in relation to FIG. 2 .

In some embodiments, the liquid may have some or all of the samecharacteristics as the liquid 106 depicted in FIG. 1 , and/or the liquid204 depicted in FIG. 2 . For example, the liquid 204 may be water, maybe of a temperature greater than or equal to about 30° C., 35° C., 40°C., 50° C. 60° C., 70° C., 80° C., 90° C., 100° C. and/or the like, andmay be of an amount to produce peroxyacetic acid in concentrations ofone or more of the following: between 500 parts per million (ppm) andabout 22002200 ppm, between about 800 parts per million (ppm) and about1600 ppm, between about 1000 ppm and about 1400 ppm, approximately 1200ppm and/or the like.

In some embodiments, the method 400 may include combining the liquid andthe solid chemistry in a first container to produce a fluid mixture(block 408). In some embodiments, the fluid mixture produced from thecombination of the liquid and the solid chemistry may have some or allof the same characteristics as the fluid mixture 112 depicted in FIG. 1and/or the fluid mixture 212 depicted in FIG. 2 . For example, the fluidmixture may be peroxyacetic acid and produced in concentrations of oneor more of the following: between 500 parts per million (ppm) and about2200 ppm, between about 800 parts per million (ppm) and about 1600 ppm,between about 1000 ppm and about 1400 ppm, approximately 1200 ppm and/orthe like.

In some embodiments, the force on the liquid due to gravity and/or anexternal force applied to the liquid (e.g., by a pump) may facilitatecombining the liquid and the solid chemistry due to the turbulence ofthe liquid. Additionally or alternatively, the method 400 may includemixing the liquid and the solid chemistry using a mixer (block 410). Themixer may be any kind of mixing device that is capable of mixingliquids. In some embodiments, the mixer may be incorporated into,included in, and/or coupled to the first container. After the liquid andsolid chemistry are in the first container, the mixer may then mix theliquid and the solid chemistry to facilitate the combination of theliquid and the solid chemistry.

In some embodiments, the method 400 may include filtering the mixture(block 412). In some embodiments, a filter (e.g., the filter 120depicted in FIG. 1 and/or the filter 308 depicted in FIG. 3 ) may beused to filter the mixture. For example, the filter may be a 100 micronfilter, a 20 micron filter, a 10 micron filter, a 5 micron filter, a 1micron filter, a 0.5 micron filter, a 0.1 micron filter and/or the like.

In some embodiments, the method 400 may include receiving the mixture(block 414). In some embodiments, the mixture may be received by asecond container (e.g., the second container 118 depicted in FIG. 1and/or the second container 218 depicted in FIG. 2 ) from the firstcontainer. In some embodiments, the mixture may be provided from thefirst container to the second container via a conduit and/or via anorifice (e.g., the orifice 214 depicted in FIGS. 2 and 3 ). In someembodiments, a pump (e.g., the pump 108 and/or the pump 122 depicted inFIG. 1 ) may pump the mixture from the first container to the secondcontainer. In some embodiments, the pump may pump the mixture from thefirst container to the second container at a flow rate of, for example,greater than about 0.5 gallons (gal)/minute (min), greater than about0.75 gal/min, greater than about 1.0 gal/min, greater than about 1.25gal/min, greater than about 1.5 gal/min, greater than about 1.75gal/min, greater than about 2.0 gal/min and/or the like. Additionally oralternatively, gravity may facilitate the mixture being received by thesecond container, for example, as explained above in relation to FIG. 2.

In some embodiments, the method 400 may include combining the mixtureand an acid in the second container to produce a disinfectant solution(block 416). In some embodiments, the mixture may be combined with theacid to lower the pH of the mixture, as described above in relation toFIGS. 1-2 . In some embodiments, the acid may have some or all of thesame characteristics as the acid 116 depicted in FIG. 1 and/or the acid220 depicted in FIG. 2 . For example, a quantity of an acid may be usedto lower the pH of the mixture, so that the combined solution has a pHof one or more of the following: a pH between about 5.0 and 7.0, a pHbetween about 6.0 and 7.0, a pH of approximately 6.5 and/or the like.Additionally or alternatively, in some embodiments, the acid may beincluded in a surfactant (e.g., Pluronic F68™ or Pluronic F68LF) tofacilitate the combination of the fluid mixture and the acid.Additionally or alternatively, the acid may be combined with thesurfactant or other liquid that is at a lower temperature than the fluidmixture so that the disinfectant solution will have a lower temperaturethan the fluid mixture. For example, the acid may be combined with asurfactant or other liquid that is at a temperature so that thedisinfectant solution will have a temperature of approximately 20° C.,25° C., 30° C., 35° C., 40° C. and/or the like.

In some embodiments, the solid chemistries and the acid may be includedin a single package and shipped to a facility that combines the solidchemistries with a liquid, as described above, and then combines theacid with the mixture resulting from the mixture of the solidchemistries and the liquid. In some embodiments, the solid chemistriesand the acid are included in different compartments of the singlepackage. As described above, this may eliminate the drawbacks ofshipping a liquid disinfectant. For example, by shipping solidchemistries and an acid, shipping costs may be less than when shippingliquid disinfectants, the shelf life of the solid chemistries and theacid may be longer than liquid disinfectants, and the solid chemistriesand the acid may be shipped via more methods than shipping liquiddisinfectants (e.g., via air).

In some embodiments, the combined solution, also referred to herein asthe disinfectant solution, produced from the combination of the mixtureand the acid, may have some or all of the same characteristics as thedisinfectant solution 126 depicted in FIG. 1 and/or the disinfectantsolution 222 depicted in FIG. 2 . For example, the mixture may beperoxyacetic acid and produced in concentrations of one or more of thefollowing: between 500 parts per million (ppm) and about 2200 ppm,between about 800 parts per million (ppm) and about 1600 ppm, betweenabout 1000 ppm and about 1400 ppm, approximately 1200 ppm and/or thelike.

In some embodiments, the force due to gravity and/or an external forceapplied to the mixture (e.g., by a pump) may facilitate combining themixture and the acid due to the turbulence of the mixture and the acid.Additionally or alternatively, the method 400 may include mixing themixture and the acid (block 418). In some embodiments, the mixer may beincorporated into, included in, and/or coupled to the second container.Before, during or after the mixture and the acid are in the secondcontainer, the mixer may be started to facilitate the combination of themixture and the acid to produce the disinfectant solution when themixture and acid are in the second container. The mixer may be any kindof mixing device that is capable of mixing liquids. In some embodiments,the method 400 may include filtering the disinfectant solution (block420). In some embodiments, a filter (e.g., the filter 132 depicted inFIG. 1 ) may be used to filter the mixture. For example, the filter maybe a 100 micron filter, a 20 micron filter, a 10 micron filter, a 5micron filter, a 1 micron filter, a 0.5 micron filter, a 0.1 micronfilter and/or the like.

In some embodiments, the method 400 may include providing thedisinfectant solution to a user and/or a medical device cleaningapparatus (e.g., an endoscope reprocessor) in order to disinfect amedical device (e.g., an endoscope) (block 422). In some embodiments,the method 400 may also include disinfecting the medical device usingthe disinfectant solution (block 424).

Although the term “block” may be used herein to connote differentelements illustratively employed, the term should not be interpreted asimplying any requirement of, or particular order among or between,various blocks disclosed herein. Similarly, although illustrativemethods may be represented by one or more drawings (e.g., flow diagrams,communication flows, etc.), the drawings should not be interpreted asimplying any requirement of, or particular order among or between,various steps disclosed herein. However, certain some embodiments mayrequire certain steps and/or certain orders between certain steps, asmay be explicitly described herein and/or as may be understood from thenature of the steps themselves (e.g., the performance of some steps maydepend on the outcome of a previous step). Additionally, a “set,”“subset,” or “group” of items (e.g., inputs, algorithms, data values,etc.) may include one or more items, and, similarly, a subset orsubgroup of items may include one or more items. A “plurality” meansmore than one.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentdisclosure. For example, while the embodiments described above refer toparticular features, the scope of this disclosure also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present disclosure is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

What is claimed is:
 1. A method for producing a disinfectant solution for disinfecting a medical device, the method comprising: combining water, sodium percarbonate and tetraacetylethylenediamine in a first container to produce a mixture comprising peroxyacetic acid, wherein the peroxyacetic acid has a concentration of at least 500 parts per million; combining an acid with the mixture in a second container to form the disinfectant solution having a pH between 5.0 and 7.0; and contacting a medical device with the disinfectant solution for a period of time between 5 to 10 minutes and within 24 hours of forming the disinfectant solution.
 2. The method of claim 1, wherein combining the water, the sodium percarbonate and the tetraacetylethylenediamine comprises mixing the mixture with a mixing device.
 3. The method of claim 1, wherein combining the acid with the mixture comprises mixing with a mixing device.
 4. The method of claim 1, wherein combining the water, the sodium percarbonate and the tetraacetylethylenediamine comprises directing water to the first container at a first flow rate of at least 1 gallon per minute and reacting sodium percarbonate and tetraacetylethylenediamine with the water in the first container, and wherein combining the acid with the mixture comprises receiving the mixture from the first container in the second container at a second flow rate of at least 1 gallon per minute.
 5. The method of claim 1, wherein the acid is a solid organic acid.
 6. The method of claim 1 wherein the water has a temperature of at least 30° C.
 7. The method of claim 1, wherein combining the water, the sodium percarbonate and the tetraacetylethylenediamine comprises combining amounts of the water, the sodium percarbonate and tetraacetylethylenediamine to produce peroxyacetic acid in a concentration between 500 parts per million and 2200 parts per million.
 8. A method for producing a disinfectant solution for disinfecting a medical device, the method comprising: combining water, sodium percarbonate and tetraacetylethylenediamine to produce a mixture comprising peroxyacetic acid, wherein the peroxyacetic acid has a concentration of at least 500 parts per million; filtering the mixture; thereafter combining an acid with the filtered mixture to form the disinfectant solution having a pH between 5.0 and 7.0; and contacting a medical device with the disinfectant solution for a period of time between 5 to 10 minutes and within 24 hours of forming the disinfectant solution.
 9. A method for producing a disinfectant solution for disinfecting a medical device, the method comprising: combining water, sodium percarbonate and tetraacetylethylenediamine to produce a mixture comprising peroxyacetic acid, wherein the peroxyacetic acid has a concentration of at least 500 parts per million; combining an acid with the mixture to form the disinfectant solution having a pH between 5.0 and 7.0; filtering the disinfectant solution; and contacting a medical device with the filtered disinfectant solution for a period of time between 5 to 10 minutes and within 24 hours of forming the disinfectant solution.
 10. A method comprising: providing, to a user, sodium percarbonate and tetraacetylethylenediamine in a first compartment of a package and an acid in a second compartment of the package; providing instructions to the user to combine the sodium percarbonate and the tetraacetylethylenediamine with water, wherein the water, sodium percarbonate, tetraacetylethylenediamine react within the first compartment to produce a mixture comprising peroxyacetic acid; and providing instructions to the user to combine the mixture with the acid, wherein the mixture and the acid to produce a disinfectant solution for use with disinfecting a medical device, wherein the disinfectant solution has a pH between 5.0 and 7.0. 